R&D Engineer II

Envista Dentistry•Pomona, CA

2d•Onsite

About The Position

This R&D Engineer II will be responsible for initiating, planning and executing research and technology development activities primarily for orthodontic fixed appliance products. In this role the engineer will generate product ideas based on market, industry and technology trends; initiate and prove feasibility of ideas, should have a very good understanding / working knowledge with all activities pertaining to technology development, business development, and product development to drive design and commercialization of orthodontic products, including the ability to interpret mechanical drawings. Creates formal networks with key internal decision makers and external parties (customers, vendors, etc.) for the organization. Must have 4-5 years of experience in a project, cross-functional environment with 3D CAD designing experience. Background in medical device manufacturing is a plus. Will be responsible for designing and developing robust products and support manufacturing methodologies. Qualified candidate must possess a ‘can-do’ attitude and must be able solve complex problem and challenges to set up new processes, improve efficiency, and maintain quality of the product.

Requirements

Understanding of ASME Y14.5 standards and Geometric Dimensioning and Tolerancing (GD&T) is essential.
Candidate must be proficient in interpreting complex mechanical drawings and applying GD&T principles to ensure design intent, manufacturability, and quality control.
Must be able to convert 2D mechanical drawing files to 3D CAD models.
Must possess 4-5 years of knowledge in SolidWorks and PDM, or other equivalent 3D CAD software.
Proficient in MS Office Suite, statistical methods.
Professional verbal and written communication skills.
Ability to translate voice of customer into product requirements.
Demonstrate out-of-the-box thinking.
Handle all initial patent disclosure and IP of new technologies.
Conveying all known patent and IP research to internal counsel and support prosecution.
Ability to communicate effectively across the enterprise, as well as various groups such as Regulatory, QA/QC, Supply Chain, Marketing, Customer Service, Sales) and external customers and suppliers.
The employee is regularly required to sit.
The employee is frequently required to walk.
The employee is occasionally required to stand.
The employee must occasionally lift and/or move up to 10 pounds.

Nice To Haves

Background in medical device manufacturing is a plus.
Advanced knowledge of ceramics, polymers, metals, and other potentially hazardous chemicals is a plus.
Knowledge of phase-gate process of new and existing products is a plus.
Additive manufacturing technologies (3D Print) is a plus.
FEA (Finite-Element-Analysis) experience is a plus.
Degree in mechanical engineering is highly preferred.
Experience in leading project is highly preferred.
Medical device regulatory experience a plus.
Dental products/materials experience a plus.
General understanding of good laboratory practices (GLP) is a plus.

Responsibilities

Lead the execution of assigned tasks and ensure goals are met on a timely manner.
Research and develop best practices and routines to develop products and suggest output improvements.
Participate in design reviews and collaborate with engineers to validate the design.
Work and collaborate with cross-departmental engineers to develop test protocols, reports, and risk assessments.
Develop best practices, routines, and innovative solutions to improve production rates and quality of output.
Ensure equipment meets all safety, quality, and efficiency standards through IQ, OQ, and PQ before released to production.
Research, suggest, and/or implement new materials that can improve product’s performance and review scientific literature to form supporting evidence.
Leverage automation tools to streamline manufacturing processes.
Must possess experience in mechanical test equipment and other relevant laboratory processes/equipment for common hardware tests.
Prepare advanced technical reports and white papers.
Summarizes and communicates data of a complex nature to non-technical audiences.
Able to lead small to intermediate projects with minimal supervision; is accountable for results and owns the data.
Suggest experimental approaches to complex problems and carry out investigations independently.
May support all phases of product development including manufacturing scale, design control, packaging, documentation, data generation, and performance verification and commercialization.
Applies research and principles of engineering to the planning, design, development, documentation, and testing/debugging of a variety of instruments, equipment, systems and/or software.